Deva Holding AS - Cerkezkoy Subesi: Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S.,

Is my product affected?

Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

• Brand TEMOZOLOMIDE

Check against the official notice below — it lists the full affected range.

What happened

Deva Holding AS is recalling Temozolomide Capsules, 140 mg, distributed nationwide in the USA due to potential cross contamination with beta lactam products during manufacturing. The recall affects two package sizes: 5-count bottles (NDC 67877-540-07) totaling 7,380 bottles and 14-count bottles (NDC 67877-540-14) totaling 10,332 bottles. Multiple lot numbers are affected with expiration dates ranging from September 2019 through September 2020.

The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.

Details from the source

Reason for recall: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Distribution: Nationwide in the USA. Quantity: a) 7380 bottles; b) 10332 bottles Lot/code info: Lot #: a) A063581, A063462, A063460, Exp 09/30/2019; A063582, Exp 10/31/2019; A069129, Exp 05/31/2020; A071801, Exp 09/30/2020; b) A063639, A063624, A063609, Exp 09/30/2019; A063657, Exp 10/31/2019; A069366, Exp 05/31/2020; A071817, A071819, A071818, Exp 09/30/2020

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals I2019-07-23

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